Keep calm, and don't forget to carry out your post-market clinical follow-up… Post-market clinical follow-up (PMCF) is a systematic, proactive, and documented process where medical device manufacturers collect clinical data based on the intended use of their devices. The goal is to confirm the clinical performance and safety of the device throughout its lifecycle while it is on the market. PMCF also helps determine the acceptability of identified risks and detect emerging risks based on factual evidence. This continuous monitoring is crucial for ensuring ongoing patient safety and regulatory compliance. By gathering and analysing real-world data, manufacturers can address any potential issues early and maintain the high standards required for medical devices. Find out more ➡️ https://lnkd.in/eqSjhTaw #HardianHealth #Regulation #Startups #HealthTech #DigitalHealth
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Do you have a medical device ready to launch and need a boost on the regulatory front? The CPI MedTech Accelerator, a programme from the Office of Life Sciences and the Department for Science, Innovation, and Technology, is designed to help SMEs navigate the complexities of medical device regulations and they are offering up to £30,000 in funding to support that process. This £30,00 can kickstart your regulatory strategy, fund a quality management system deployment, medical writing for your clinical evaluation report, work on your software development lifecycle documentation, or engage with the FDA for international export. Having worked with several SMEs through this programme, Hardian knows what it takes to streamline compliance and get devices closer to market. Interested? We can map out what’s possible within the budget and start strong, but you need to be quick! The deadline is 31st October and spaces are limited to 300 applications! Find out more and apply here: https://lnkd.in/eJY9AhjN #HardianHealth #Regulation #Startups #HealthTech #DigitalHealth
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Bringing a MedTech Product into the world involves a lot of Clinical, Regulatory & Testing Efforts. Navigating the Medical Regulatory landscape based on your Product Classification & Stage is fraught with a lot of challenges & unknowns. Impact : These challenges delay the overall Product Delivery Launch Timelines & your Go-To-Market (GTM) Plans, postponing your Revenue goals. We in GTM4Health are exploring building a "Medical Devices Quality & Regulatory Services" offering to assist MedTech Startups. If you are a Company/Startup facing these challenges, please fill up the form below given in comments. We will reach out to you. #Regulatory #Compliance #GTM
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🌟 Navigating the Regulatory Labyrinth in MedTech: A Path to Innovation and Safety 🌟 In the fast-paced world of medical technology, the path from concept to market is fraught with challenges. Yet, one aspect remains paramount: adherence to regulations. It's not just about compliance; it's about commitment to excellence and patient safety. 🚀 At 1Med.Tech, we understand that navigating the intricate world of MedTech regulations can be daunting for startups. That's where we step in. As your dedicated MedTech consultant, we specialize in demystifying the complexities of QMS implementation and crafting bespoke regulatory strategies that clear the way for innovation, while ensuring the highest standards of safety and quality are met. 💡 Why are regulations so crucial in MedTech? Patient Safety: At its core, regulations protect those who matter most – the patients. Ensuring your product meets stringent safety and efficacy standards is not just a regulatory requirement; it's a moral one. Market Access: Compliance is the key to unlocking global markets. Each region comes with its own set of regulatory hurdles. Tailored strategies can streamline this process, saving time and resources. Innovation Integrity: Regulations ensure that innovations maintain a focus on real-world application and patient benefit, guiding technologies to be both groundbreaking and grounded in safety. We at 1Med.Tech are passionate about empowering startups to turn their visionary ideas into realities that enhance healthcare outcomes worldwide. By partnering with us, you gain more than just regulatory guidance; you gain a collaborator invested in your success. Let's transform challenges into opportunities and pave the way for the next generation of medical technology together. 🌐✨ #medicaldevices #regulatorycompliance #healthcare #Innovation #1MedTech #qualitymanagementsystem
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Let’s talk about traceability in medical device requirements… When it comes to regulatory submissions, managing a requirements stack across the total product life cycle seems daunting. At Hardian, we've made it easier by organising these requirements into tiers, ensuring clear traceability from user needs to design outputs. This approach helps manage verification, validation, and ongoing maintenance. Getting this right means your technical documentation stays organised and compliant from initial submission to post-market surveillance. If you’d like to learn more about staying compliant throughout the product lifecycle, read our latest blog ➡️ https://lnkd.in/eUEh2uuK Need support optimising your requirements management for medical devices? Contact Hardian today ➡️ https://lnkd.in/ecUMAN9t #HardianHealth #Regulation #Startups #HealthTech #DigitalHealth
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Bringing a MedTech Product into the world involves a lot of Clinical, Regulatory & Testing Efforts. Navigating the Medical Regulatory landscape based on your Product Classification & Stage is fraught with a lot of challenges & unknowns. Impact : These challenges delay the overall Product Delivery Launch Timelines & your Go-To-Market (GTM) Plans, postponing your Revenue goals. We in GTM4Health are exploring building a "Medical Devices Quality & Regulatory Services" offering to assist MedTech Startups. If you are a Company/Startup facing these challenges, please fill up the form below given in comments. We will reach out to you. #Regulatory #Compliance #MedTech
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Innovating in the medical device sector is a journey full of potential and pitfalls. For startups, navigating this terrain can be particularly challenging due to the complexity of regulatory requirements, quality management, and market expectations.💡 Samantha Shelley, an expert in medical device quality and regulatory affairs, shares insights into the common obstacles and strategies for overcoming them. Read more through the link in the comments! #HealthTech #MedicalDevice #Innovation
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EMPOWER Medical Device Solutions is on a mission: to empower your medical device startup to regulatory success. With a foundation built on industry knowledge and a commitment to each client's success, we’re not just a service—we’re your strategic regulatory partner. Our suite of services is designed to ensure that every step you take is aligned with your business goals. It's not just what we do; it's how we do it. With the values of mastery and integrity informing our every move, we strive for excellence that translates into real-world achievements for your medical device startup. We invite you to connect, share your experiences, and discuss the challenges you face in navigating medical device regulations. Together, we can overcome these hurdles and bring your innovations to market. Discover how EMPOWER Medical Device Solutions can support your startup's journey to regulatory success by visiting us at https://lnkd.in/gtrhFPr7. #MedTech #MedicalDevices #Regulatory #Startup #medicaltechnology #regulatorycompliance
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#DigitalHealth #Startups: 💰 Discover EU-Funded Collaborations at R2GConnect.com InnoBuyer is looking for : QMS-tool for MDR compliance of early-stage medical device development https://bit.ly/3t6cDRL 🤝 What's in it for you? ✔️ €58,500 per SME/Start-up; ✔️ 10-month Co-creation / #Pilot; The challenger: Delft University of Technology (TUD), a leading technical university located in The Netherlands. Challenge: According to the European Commission, 500,000 medical devices are currently on the market, with approximately 10,000 new additions annually. The MDR, a European Union regulation, becomes applicable on December 31, 2027, for higher risk devices and on December 31, 2028, for medium and lower risk devices. To comply with the MDR, designers and engineers must furnish comprehensive documentation, quality control evidence, and clinical evidence demonstrating product safety and efficacy. 🕒 Don't miss out! 🔗 Apply on R2GConnect: https://bit.ly/3t6cDRL #digitalhealth #globalhealth #healthcare #innovationmanagement #partnerships #codevelopment #pilot
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When it comes to EU medical device regulation 'EUDAMED' is a term you'll be hearing a lot. EUDAMED is the European database for medical devices – a key element of the new EU Medical Device Regulation. EUDAMED is designed to enhance transparency and coordination between device manufacturers, regulators, and the public. By compiling information on medical devices and their manufacturers, it aims to ensure the highest level of patient safety and market oversight. Just a heads up; the database will soon be mandatory for manufacturers, so engaging with this platform is crucial for anyone operating in the medical device sector! Find out more ➡️ https://lnkd.in/dRrdMq8 #hardianhealth #regulation #startups #samd #digitalhealth
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➡️ Insight: We have noticed that medical device startup founders come with very similar questions regarding medical regulations and certification. The person addressing these questions at Consonance is Sabina Matysiak - Quality Manager, R&D Engineer. Search no more! Click and get familiar with some answers by reading a short intrview! 💬 https://lnkd.in/dhNtpqHf #medicalregulations #mdr #fda #medicalcertification #medicaldevice #startup #medtech
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